FDA Law Blog

SEPTEMBER 20, 2021

Below we provide an overview of some of the goals letter’s most notable contents such as new initiatives as well as some large-scale enhancements to programs that have already been in the works. Pandemic influences aside, the FY 2023-2027 goals letter contained many notable new initiatives, announcements, and commitments.

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Patient-Centered Manufacturing Clinic Provider 52

FDA Law Blog

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

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Manufacturing Provider Physicals Electronics 64

FDA Law Blog

JUNE 14, 2023

He highlighted the following key features of TAP: An Innovative Approach To provide proactive support and guidance to medical device manufacturers, FDA has introduced a new CDRH position known as the “TAP Advisor.” up to 225 total products enrolled through FY 2026 and up to 325 total products enrolled through FY 2027).

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Manufacturing Medical Appointment Patient-Centered 45

FDA Law Blog

FEBRUARY 20, 2025

That, of course, is not unique to labs with LDTs; kit manufacturers also need to obtain those insights well before they begin studies.) FDA had been scheduled to hold a webinar on the Stage 2 (May 2026) requirements related to the investigational device requirements for LDTs later this month.

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Patient-Centered Consulting Government Clinic 102